Medical Director Clinical Development

Company Summary:

We're partnering with a mid‑sized biotech leading the way in endocrine and orphan lung disease therapeutics. With two FDA‑approved products generating over $300 million in revenue last year, the company is scaling rapidly and building on real commercial success. Their innovative inhaled delivery platform supports small molecules and biologics, creating a versatile foundation for future programs. You'll have the chance to work on a pipeline backed by proven, clinically validated science, while contributing to the next wave of breakthrough therapies.

If this excites you, we encourage you to apply and learn more.

Primary Responsibilities:

• Lead clinical trials with full GCP compliance.
• Manage recruitment, data quality, medical monitoring, and safety oversight.
• Oversee CRO activities and collaborate with Biostats, Data Management, and Clinical Operations.
• Ensure regulatory alignment, data integrity, and quality assurance.
• Support strategy and design for Phase 1-4 trials.
• Review literature, define eligibility criteria/endpoints, and evaluate data using modeling tools.
• Serve as clinical study lead.
• Prepare regulatory documents (IND, NDA) and contribute to clinical protocols, reports, and submissions.
• Present to internal committees and support first-in-human meetings.
• Analyze and communicate study data internally and externally.
• Partner with Medical Directors, Medical Writing, Drug Safety, Translational Medicine, Regulatory, CROs, investigators, advisory boards, and KOLs.
• Represent Clinical Development on project teams; may serve as project lead.
• Present updates to senior management and contribute to business development/due diligence.
• Provide medical, clinical, and safety support in endocrinology.
• Perform other duties as needed.

Ideal Qualifications:

• 3+ years clinical development experience in industry.